1. Field of the Invention
The present invention relates to processes for producing chewing gums containing active ingredients. In particular, the present invention relates to a process for preparing a chewing gum tablet containing one or more nutritional supplements.
2. Background Technology
Conventional chewing gum processing technology involves melting a gum base in, for example, a sigma blender, and adding components such as sweeteners and flavorants to the melt. The melted mass is then extruded, rolled into sheets, and cut to the desired shape on the rollers. This conventional technology, however, suffers from several disadvantages when applied to the preparation of chewing gums containing active ingredients. For example, the elevated temperatures used in forming the melt can adversely affect the chemical stability of any active ingredients contained therein. In addition, the melting and mixing process for the highly viscous gum mass makes controlling the accuracy and uniformity of the amount of active ingredient difficult, and this difficulty is further exacerbated by the lack of a precise form, shape or weight of the gum product. In addition, conventional gum processing technology is generally poorly suited for high-speed, low cost production of gum products having active ingredients.
Several patents are directed to methods of processing chewing gums which attempt to overcome some of the disadvantages described above. For example, U.S. Pat. No. 4,000,321 to Mochizuki et al. is directed to a process for preparing chewing gum, in which a chewing gum composition is cooled to xe2x88x9215xc2x0 C. to facilitate fragmentation, and the cooled composition is pulverized with a crusher, hammer mill, pelletizer or turbomill. The pulverized product is then melted to cause the pulverized pieces to co-adhere, forming a chewing gum reportedly having low specific gravity and a soft chewing texture. The process, however, suffers from all of the disadvantages associated with heating, process speed, poorly defined forms and weights described above, and is not well-suited for making a chewing gum dosage form containing an active ingredient.
U.S. Pat. No. 5,711,961 to Reiner et al. discloses a pharmaceutical chewing gum composition in tablet form made by freezing chewing gum, grinding the gum in a mill, and granulating the ground gum in a fluid bed. Thereafter, a medicinal active agent is mixed with the granulate, and the granulates are compressed into tablets.
In U.S. Pat. No. 4,975,270 to Kehoe, a medicament-active chewing gum is disclosed which is made by freezing and grinding into a particle mass an elastomer, an active agent, and silica in the presence of liquefied carbon dioxide. The particles are then shaped into a chewing gum product. In the process of Kehoe, the gum and the active ingredient are mixed together while heating, and then the mixture is frozen and ground into particles.
In U.S. Pat. No. 4,753,805 to Cherukuri et al. a chewing gum composition in the form of a tablet having a low moisture content is disclosed. The tablet is produced by grinding a chewing gum composition, granulating the ground composition, blending the granulated composition with an active agent and a compression aid, and compressing the granulated product to form a tablet. Grinding of the chewing gum composition, typically a difficult process because of the tendency for the gum to stick to the grinding apparatus, is accomplished by the use of a grinding aid such as an alkaline metal phosphate, an alkaline earth metal phosphate, or a maltodextrin. The use of such grinding aids, however, is disadvantageous. The metal phosphate salts are highly alkaline, and such alkalinity may be incompatible with certain active ingredients. In addition, the grinding aid remains in the composition and ultimately in the chewing gum tablet, and the presence of a large amount of metal phosphate is potentially problematic from therapeutic and safety perspectives.
Thus, there is a need for processes to produce active-containing chewing gums that do not suffer from the disadvantages of conventional active-containing chewing gum formulations.
The present invention relates to a process for preparing a chewing gum tablet containing a nutritional supplement and the resulting chewing gum tablet product. The process of the invention includes cooling a chewing gum composition to a temperature at which the gum composition is brittle, and grinding the cooled, brittle gum composition to form a chewing gum powder. The composition can be cooled by mixing it with a coolant, such as solid carbon dioxide, prior to grinding. The chewing gum powder is mixed with an active composition comprising a nutritional supplement, such as one or more vitamins, minerals, or herbs, to form a nutritional supplement-containing powder. The mixture of powder and nutritional supplement, along with other optional additives, is then granulated to form nutritional supplement-containing granules. These granules are then compressed to form chewing gum tablets.
In another aspect, the present invention is directed to a chewing gum tablet comprising a plurality of granulated particles compressed to form the tablet. The granulated particles comprise a chewing gum composition and a nutritional supplement, along with any other ingredients added during processing to form the tablet. The granules forming the tablet can be of a size suitable for tabletization methods.
These and other features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.